Zyprexa Gets FDA Attention Following Two Patient Deaths

Zyprexa is an antipsychotic medication manufactured by Eli Lilly used to treat disorders such as schizophrenia and bipolar disorder. This drug, however, has caught the attention of the U.S. Food and Drug Administration (FDA) when two patients died after receiving the injections. The FDA is now investigating Zyprexa, which is manufactured by Eli Lilly.

Zyprexa generated $1.7 billion in revenue for Eli Lilly last year, according to Bloomberg. Sales peaked in 2010 at $5.03 billion.

The long-acting form Zyprexa is approved with risk evaluation and mitigation strategy, meaning that patients have to remain in the clinic for 3 hours after the injection so they can be monitored for any signs of complications. The patients are also supposed to be escorted home. These measures were put in place after some patients became delirious and lost consciousness after receiving injections during clinical trials.

In a statement issued today, the agency said “At this time, FDA is continuing to evaluate these deaths and will provide an update when more information is available,” According to the FDA, the patients received correct dosages and so far there is no evidence to suggest that the deaths were caused by an overdose. The tests for both patients had “very high olanzapine blood levels after death” the agency said. High levels of Zyprexa can cause delirium, cardiopulmonary arrest, cardiac arrhythmias and impaired consciousness, which can range from sedation to a coma.

These troublesome symptoms are known as post-injection delirium sedation syndrome (PDSS). PDSS are thought to be caused by an unexpectedly rapid release of the drug in the blood circulation.

Zyprexa injections are given every 2-4 weeks for treating patients with schizophrenia. It is one of several long-acting “atypical” antipsychotic drugs currently on the market. PDSS has not yet been seen with other similar products.